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THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY
USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT
POLICY
Date:
GAIN Report Number:
Approved By:
Prepared By:
Report Highlights:
This report outlines regulatory requirements for food and agricultural product imports into Brazil,
including import procedures. There were no significant changes to Brazilian regulations within 2014,
however, new significant requirements are expected to be implemented during 2015.
Fabiana Fonseca, Agricultural Marketing
Specialist
Michael Fay, ATO Director
FAIRS Country Report
Food and Agricultural Import Regulations and Standards -
Narrative
Brazil
BR14009
12/15/2014
Required Report - public distribution
Section I. Food Laws:
___________________________________________________________________________________
This report was prepared by the US Agricultural Trade Office (ATO) of the USDA/Foreign Agricultural
Service in Sao Paulo, Brazil for US exporters of domestic food and agricultural products. While every
possible care has been taken in the preparation of this report, information provided may not be
completely accurate either because policies have changed since its preparation, or because clear and
consistent information about these policies was not available. It is highly recommended that U.S.
exporters verify the full set of import requirements with their foreign customers, who are normally best
equipped to research such matters with local authorities, before any goods are shipped. Final import
approval of any product is subject to the importing country’s rules and regulations as interpreted by
border officials at the time of product entry.
_________________________________________________________________________________
Brazil is a member of the World Trade Organization (WTO) and therefore has made commitments to
subscribe to the Sanitary and Phytosanitary (SPS) Agreement and to Codex Alimentarius (CODEX)
principles. The country is also a member of the Common Market of the South (Mercosul) formed by
Argentina, Brazil, Paraguay (which is currently suspended), Uruguay and Venezuela. The Customs
Union allows duty free tariff among member states and imposes a common external-tariff on non-
member countries. It also establishes a common commercial policy toward third countries.
Food regulations issued at the federal level are contained in various types of legal documents and, in
order to be implemented must be published in Brazil’s Diario Oficial (similar to the U.S. Federal
Register). Brazil has three levels of government: federal, state and municipal. Legally, federal
regulations must be followed when there are conflicts between federal, state and municipal legislation,
or between regulations established by different ministries at the federal level. State and municipal
governments also have the authority to regulate and enforce state and municipal laws.
In the federal government, numerous agencies and several ministries share jurisdiction for ensuring the
safety of the Brazilian food supply and regulating imports of agricultural commodities and foods.
However, the Ministry of Agriculture, Livestock, and Food Supply (MAPA) and the Ministry of Health
(MS) - through its National Agency of Sanitary Surveillance (ANVISA) - are the primary regulators of
agricultural products. MAPA oversees and enforces a large number of regulations pertaining to
production, marketing, import and export of animal origin products, fresh fruit and vegetables, alcoholic
beverages, juices, grains, seeds, and animal feed (including pet food). ANVISA enforces most
regulations regarding processed food products. MAPA and ANVISA’s regulations may be consulted
on-line. On MAPA’s website (www.agricultura.gov.br) the search tool SISLEGIS makes available the
current regulations on products that are under MAPA’s supervision. A similar search tool called
VISALEGIS can be found at ANVISA’s website (www.anvisa.gov.br).
Other ministries and/or agencies also involved in monitoring/control of food safety include the
Environment Protection Institute (IBAMA), of the Ministry of the Environment; the National Institute
of Metrology, Standardization and Industrial Quality (INMETRO) of the Ministry of Development,
Industry and Commerce (MDIC); the National Technical Commission on Biosafety (CNTBio), which is
an Inter-Ministerial Commission based in the Ministry of Science and Technology (MCT); and the
Department of Consumer Protection and Defense (DPDC) within the Ministry of Justice.
The Brazilian constitution defines the relationship between federal, state and municipal law. It also
defines the power of each federal branch of government (legislative, judicial and executive). As the
executive power and its branches exercise authority to legislate activities related to foreign trade and
food safety, importers/exporters may observe the set of rules each administrative agency releases as it
direct impacts market access for foreign goods. Although Congress has responsibility for rule making,
the power delegated to the Ministries and its various branches are considerable as they implement those
rules and define in greater details the procedures that must be followed. In terms of the enforcement of
sanitary legislation overall, the principle of “positive legislation” is in place. That is, only that which is
expressly established can be practiced. That which is not expressly addressed is prohibited.
Section I.I. Ministry of Agriculture, Livestock and Food Supply (MAPA)
The Ministry of Agriculture, Livestock and Food Supply (MAPA), under the premise of safeguarding
animal and plant health, is responsible for formulating and executing all policies related to Brazilian
agribusiness development. MAPA integrates science, technology, and market aspects to respond to
domestic and international demand. MAPA’s functions include the regulation, classification and
inspection of imported agricultural products entering Brazil. The major offices, called Secretariats, are:
Secretariat of Agricultural Protection (SDA); Secretariat of Agricultural Policy (SPA); Secretariat of
Agriculture and Livestock Development and Cooperativism (SDC); Secretariat of Production and Agro-
Energy (SPAE), and, Secretariat of International Agribusiness Relations (SRI). MAPA’s regulatory
activities of interest to this report are primarily enforced by SDA, SDC and SRI.
The Secretariat of Agricultural Protection (SDA)
SDA through its six main departments is responsible for enforcing regulations related to domestic and
imported plants and animals, including their respective products and by-products, and other inputs such
as feed (including pet food), fertilizers, pesticides, and contaminants. Additionally, the General
Coordination for Sanitary Inspection on Agriculture and Livestock (VIGIAGRO), also under SDA,
responds for surveillance of all foreign products entering Brazilian borders.
Department of Animal Origin Products Inspection Service (DIPOA)
DIPOA is responsible for ensuring that all animal origin products (meat derived from cattle, sheep,
swine, goats, horses, game meat, poultry, dairy products, eggs, seafood, honey and other products with
more than 50 percent of animal origin composition) moving in interstate and foreign commerce are safe,
wholesome for consumption, and accurately labeled. Under DIPOA there are 3 divisions overseeing
meat, dairy and seafood products:
-Division of Meat and by-products Inspection (DICAR)
-Division of Milk and by-products Inspection (DILEI)
-Division of Seafood and by-products Inspection (DIPES)
Department of Plant Origin Products Inspection Service (DIPOV)
DIPOV has the regulatory authority to enforce federal laws regarding the registration, compliance and
labeling of alcoholic and non-alcoholic beverages such as distilled spirits, wine, soft drinks and juices
(except beverages for sport practices, water, energy drinks). Under DIPOV there is one branch for
beverages:
- General Coordination for Wine and Beverages (CGVB), which is divided in two Divisions:
-Division of Alcoholic and Non-alcoholic Beverages, excluding wine (DBEB)
-Division of Wine and by-products (DVB)
Department of Animal Health (DSA)
DSA is responsible for enforcing regulations on imports and exports of live animals, semen, embryos.
In cooperation with state governments, DSA enforces federal laws and regulations to protect and
improve animal health, and to control and eradicate animal diseases such as the Foot-and-Mouth
Disease Eradication Program. It defends Brazilian borders against foreign and exotic animal diseases.
Department of Plant Health (DSV)
DSV is responsible for protecting the health of plants, and preventing the introduction and spread of
foreign pests within Brazil.
Department of Surveillance of Agricultural Inputs (DFIA)
DFIA is responsible for the regulatory inspection and registration of all planting seeds and seeding
(including biotech seeds), as well as for establishing standards for agricultural products such as grains,
fruits and vegetables.
Department of Surveillance of Livestock Inputs (DFIP)
DFIP is responsible for the regulatory inspection of feed for animal consumption (including pet food),
the registration of establishments producing animal semen and embryos, and the genealogical
registration of live animals. DFIP also regulates the use of veterinary products.
General Coordination for Sanitary Inspection on Agriculture and Livestock
(CGVIGIAGRO)
CGVIGIAGRO is responsible for inspection and clearance of foreign products under MAPA’s
jurisdiction at Brazilian ports and airports. VIAGIAGRO also establishes the documents and procedures
international companies must follow to have products cleared to enter the country.
The Secretariat of Agriculture and Livestock Development and Cooperativism (SDC) One of SDC’s functions is to regulate organic sector from the early stages of production until processing
and trade. The Department overlooking organic issues is
- Department of Production Systems and Sustainability (DEPROS), which has recently created a new
division:
-Agroecology Coordination (COAGRE)
The Secretariat of International Agribusiness Relations (SRI)
SRI is responsible for coordinating the Brazilian government positioning on agricultural matters during
international forums such as the World Trade Organization (WTO), Office of International Epizootics
(OIE), International Plant Protection Committee (IPPC), and Codex Alimentarius (CODEX). SRI also
coordinates regional and bilateral agricultural agreements. The Secretariat is also the focal point for the
United States and Brazil negotiations under the Consultative Committee on Agriculture (CCA). SRI is
composed by three departments; two of each has a direct impact on US exports into Brazil.
Department of Commercial Affairs (DAC)
DAC is responsible for bilateral, multilateral or regional negotiations involving agriculture and
livestock.
Department of Sanitary and Phitosanitary Affairs (DASF)
DASF supports all government commitments on international negotiations regarding sanitary and
phitosanitary issues.
I.II. Ministry of Health (MS)
The Ministry of Health’s (MS) regulatory activities are enforced by an agency called National Agency
of Sanitary Surveillance (ANVISA). Within the structure of the federal public administration, ANVISA
is considered an autonomous agency. ANVISA was created to function as the scientific regulatory
agency responsible for the safety of all foods under its authority (mainly processed products). The
agency is also responsible for overseeing the production and registration of drugs, food additives,
medical devices, tobacco and tobacco products.
ANVISA’s primary function is to protect the public (i.e., human health) by assessing food standards,
safety, and contaminants. In addition, the agency is responsible for the compliance and registration of
any food processing facility established in, or exporting to, Brazil. Within ANVISA the regulation,
inspection and clearance of food products is coordinated by the following branches:
General Management for Food Products (GGALI) GGALI is responsible for the implementation of regulation and inspections of all food products under
ANVISA’s competence. The Office is formed by three offices:
Coordination for Food Regulation (CORAL)
CORAL is responsible for rule making of food products.
Risk Analysis Management and Verification (GEARE)
GEARE is responsible for product registration, analysis, control, supervision, inspection and risk
management of food products at the state and municipal level.
Superintendency of Ports, Airports, Borders and Customs Enclosure (SUPAF)
SUPAF is responsible for the clearance and inspection procedures of any food product under
ANVISA’s competence at entry ports.
International Affairs Assistance (AINTE) AINTE coordinates the Brazilian government’s commitments and proposals on food health and food
safety issues during international discussions. The board is also the primary contact for foreign
governments on legislative and market access matters.
I.III. Ministry of Environment (MMA)
Within the Ministry of Environment (MMA) the regulatory authority for activities that affect the
environment is called Brazilian Institute for the Environment and Natural Resources (IBAMA).
IBAMA is one of the key government agencies involved with approval of agricultural chemicals
(pesticides and herbicides), but has joint authority for this function with the Ministry of Health (which is
concerned with the toxicology aspects of agricultural chemicals) and the Ministry of Agriculture,
Livestock, and Food Supply (which actually provides the registration for pesticides).
IBAMA is concerned with the possible environmental impact of pesticides. In general, it follows
recommendations made by international standard setting organizations, such as the CODEX
Alimentarius, and works closely with its U.S. counterpart, the U.S. Environmental Protection Agency
(EPA). IBAMA is also the Brazilian regulatory agency that enforces the treaties established at the
Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITIES). It is the
agency responsible for monitoring and enforcing activities related to Brazilian fauna and flora.
The regulatory rules related to these subjects in Brazil can be found at www.ibama.gov.br and
www.mma.gov.br.
I.IV. Ministry of Development, Industry and Foreign Trade (MDIC)
All food products imported or exported by Brazil must be registered at the Secretariat of Foreign Trade
(SECEX) of the Ministry of Development, Industry, and Foreign Trade (MDIC). This office monitors
all import and export tariffs and issues import and export licenses. In addition, SECEX is the
government agency responsible for judging antidumping cases against foreign products.
Since January 1997, SECEX, the Secretariat of Federal Revenue (SRF) of the Ministry of Finance
(MF), and the Brazilian Central Bank (BCB) have been responsible for import related activities such as
licensing, customs clearance and exchange monitoring though the Integrated Foreign Trade System
(SISCOMEX), an administrative software program for completing import documentation requirements.
Since this system has been implemented, import and export procedures have become more transparent.
In addition, the system enables the government to better control tax payments. Only Brazilian or
multinational companies registered with the Importers and Exporters Registry Office of SECEX are
allowed to import products for commercial use. It is necessary to be registered at the SRF in order to
obtain access to the SISCOMEX.
Also under the MDIC are the National Institute of Metrology, Standardization, and Industrial Quality
(INMETRO). INMETRO also conducts tests of domestic and imported products (industrial or food
products) to make sure they meet the specifications of their labels and the safety of packaging
materials. Information on INMETRO can be found on their home page www.inmetro.gov.br. Other
MDIC legislation and procedures can be found at www.mdic.gov.br or at Diario Oficial’s website
www.in.gov.br.
I.V. Ministry of Justice (MJ)
The Department of Consumer Protection and Defense (DPDC) within the Ministry of Justice is the
federal agency responsible for enforcing the Brazilian Consumer Code (CDC), published in 1990. The
code regulates consumer claims against adulterated food products, incorrect or misleading labels, and
fraud. Each state in Brazil has an office of the Department of Consumer Protection and Defense that
assists consumers directly in pursuing their rights.
For additional information on the Ministry of Justice’s consumer department, please check the Ministry
of Justice’s home page www.mj.gov.br. Other Brazilian federal regulations regarding the Ministry of
Justice can be found at Diario Oficial’s home page www.in.gov.br.
Section II. Labeling Requirements:
MAPA and ANVISA define labeling requirements for all food products that have Product Identity and
Quality (PIQ) standards defined. If the product is permitted but not under PIQ specifications, which is
the case for few products, the importer still needs to follow the rules established by the Consumer
Protection Agency. The Brazilian Consumer Protection Law requires that all domestic and imported
foods and beverages must provide the consumer with correct, precise, clear and easily readable
information about the product in Portuguese. According to the law, the Brazilian importer is held liable
in case of health risk to the consumer of an imported product. The expiration date, or shelf life date, is
very important for Brazilian consumers and should never be overlooked. Regulatory framework for
labeling domestic and imported food products may be found under the PIQ of the specific food
category. The legislation requires the following information on labels:
Front panel
technical name (according to MAPA/ANVISA classification)
brand
quantity indication
% alcohol content (for alcoholic beverages)
For all products:
Liquid content (grams or milliliters) Minimum font height (mm)
below or equal 50 2.0
above 50 and below or equal 200 3.0
above 200 and below or equal 1000 4.0
above 1000 6.0
Side panel
list of ingredients
country of origin
contact information for the processing company
contact information for the importer
expiration date
lot number
care and handling information
instructions for product use (if necessary)
claim “contains gluten” or “does not contain gluten”
notice “evite o consumo excessivo de alcool”, which translates to “avoid excessive consumption
of alcohol” (for alcoholic beverages)
nutritional information
Nutritional labeling requirements are similar to those in force in the United States. The Nutritional
Information must be set by portion of food, and the portion listing must be accompanied by its
respective “household measurement”, for example, cup, tablespoon, and teaspoon. The label must
include the following information:
NUTRITIONAL INFORMATION
Portion of … grams (household measurement)
Quantity per portion % Daily Required (VD*)
Energy Value kcal = kJ %
Carbohydrates g %
Protein g %
Total Fat g %
Saturated Fat g %
Trans Fat g **
Dietary Fiber g %
Sodium mg %
Vitamins/Minerals
(when applied)
mg or μg %
* % daily requirements with reference to the basis in a 2,000Kcal, or 8,400kJ diet.
** daily requirement not established
The letters used for writing unit-of-measure symbols must have a minimum height of 2/3 of the height
of the algorithms.
For products without Portuguese language labels, an adhesive sticker may be used on the original label,
for the information referred to the “side panel” and “nutritional information”.
Most consumer-oriented products are exempt of labeling registration. Products with mandatory labeling
registration follow more strict control. Depending on product nature, MAPA or ANVISA may require
additional notes, such as plant number, product registration number, etc. For animal origin products,
such as meat, dairy, and seafood products, the Brazilian importer must file a request for the pre-
registration of the foreign labels. It is recommended that the exporter contact FAS/OAA Brasilia to
initiate this process. Only those products that have their labels pre-approved by DIPOA are allowed to
enter Brazil. The National Institute of Metrology, Standardization and Industrial Quality (INMETRO)
also regulates labeling. INMETRO defines bar coding and other technical issues related to label format,
layout and measurement.
Section III. Packaging and Container Regulations:
Regulations on food packaging and containers fall under ANVISA’s jurisdiction. Dairy products, are
the only exception; an additional licensed must be granted by MAPA. To obtain the Product Use
Authorization (AUP), the company must provide evidence that ANVISA’s requirements have been
fulfilled. ANVISA establishes quality and identity standards for materials, such as plastic, glass, metal,
ceramic, and cellulosic. The agency’s objective is to guarantee that packaging materials do not contain
toxic substance or cause modification to food content. Although in 2000, food packages became
exempt from registration, mandatory registration is required for recycled packaging material. As Brazil
follows the principle of positive legislation, companies that make use of new technologies have the right
to send a petition to ANVISA and request an inclusion on the list, which is subject to ANVISA’s
approval
The Brazilian Association of Technical Norms (ABNT) is responsible for elaboration of technical rules
(standards and specifications) for packaging and containers. ABNT is also a founding member of the
International Organization for Standardization (ISO), the Mercosul Standardization Association (AMN),
and the Pan American Commission for Technical Ruling (COPANT). ABNT conducts the certification
for consumer packaging (paper and carton boxes, plastic bags, steel sheet, aluminum cans, tetrapak,
PET bottles, etc). The Association also regulates the recycling of packaging and containers for food
products. All manufacturers or importers shall be responsible for the recycling, disposal and removal of
packages or containers that are likely to cause serious pollution to the environment after consumption or
use. ABNT follows the international Resin Identification Code (numbering from 1 to 7) of the Society
of Plastics Industry and the Standard Recycling Symbol. For detailed regulatory information as well as
links to the main associations of packaging and containers, access the ABNT home page at:
www.abnt.org.br.
The government’s regulatory agency involved with the quality and safety of packaging and containers
for handling food is the National Institute of Metrology, Standardization, and Industrial Quality
(INMETRO), linked to the Ministry of Development, Industry, and Foreign Trade (MDIC). For
additional information, access INMETRO’s home page at www.inmetro.gov.br.
Section IV. Food Additives Regulations:
ANVISA defines food additives as any ingredient without nutritional benefits deliberately added to food
to modify its physical, chemical, biological and sensorial characteristics during any stage - processing,
storage, handling, transportation, etc. Before approved for consumption, any food additive is analyzed
separately in order to prove its technological need and safety. This analysis includes: the relation of the
additive to the product it will be incorporated to; its functionality; studies and toxicological data which
allows an adequate risk assessment; studies on estimates of potential ingestion; regulatory framework
from other countries; and, international benchmark.
Depending on its nature, the approval or incorporation of the additive to the food regulatory framework
may occur with restrictions of use. In this case ANVISA will establish maximum limits for the active
substance for the specific food product in which the additive will be incorporated. If the additive is
approved but a safety tolerance is not set, the additive may be used at the level required to obtain desired
result.
Before exporting food and beverage products to Brazil, U.S. exporters must make sure that not only the
final product complies with the local legislation but also its ingredients, which includes the additives.
Brazilian legislation divides food products into categories. For each category, allowed additives are
listed.
Section V. Pesticides and Other Contaminants:
Brazil follows international standards on tolerances of pesticides, herbicides and fungicides on
agricultural products, and uses Codex Alimentarius as a general reference. The Codex Alimentarius
Committee of Brazil (CCAB) represents the country in international Codex Committees and advocates
for the use of Codex standards in the country.
Based on Codex norms, registration of agricultural chemical is held by a three party committee (MAPA,
IBAMA, and ANVISA). ANVISA provides toxicological analysis and establishes maximum tolerance
levels while IBAMA evaluates environmental impact. MAPA is the initial point of contact in the
product registration process and also the party that deliberates final approval after receiving inputs from
ANVISA and IBAMA.
In order to improve the inspection of pesticides and contaminants on vegetables in Brazil, in 2009 the
National Program for Pesticides and Contaminants Detection was created. The program collects samples
of domestic and imported fruit and vegetables, such as papaya, apple, pineapple, lettuce, rice, peanut,
banana, lemon, acid lime, mango, melon, corn, strawberry, pepper, tomato and grape. Imported
products must comply with the same requirements established for local products.
A list of approved pesticides may be found at the Agrofit System at MAPA’s home page
www.agricultura.com.br. Maximum tolerance levels for pesticides can be obtained at ANVISA’s
webpage www.anvisa.com.br.
Section VI. Other Regulations and Requirements:
VI.I. MAPA’s Inspection Requirements for Meat, Dairy, and Seafood Products
In order to export animal origin (beef, pork, powdered milk, whey, lactose, cheese, and seafood)
products to Brazil, the local government requires that U.S. processing plants be inspected by federal
agencies in the country of origin. The only U.S. federal agencies approved by the Brazilian
Government to certify U.S. processing plants are: the Food Safety and Inspection Service of the U.S.
Department of Agriculture (FSIS/USDA) for meat; the Agricultural Marketing Services (AMS/USDA)
or the Food and Drug Administration (FDA) for dairy and the National Oceanic and Atmospheric
Administration/National Marine Fisheries Services (NOAA/NMFS) for fishery products.
The U.S. exporter must contact these federal agencies and request the inclusion of the processing plant
in the list of approved U.S. plants to export to Brazil. The request for registration of the U.S. plant with
the Brazilian authority, DIPOA, must be done as per the following procedures:
Meat: all beef or pork plants must make a formal request to FSIS. FSIS will then contact the Foreign
Agricultural Service/Office of Agricultural Affairs (FAS/OAA) and request the registration to be
included in the Brazil’s official list.
Dairy: registration under this category must be done directly through FAS/OAA. FAS will need a
formal letter from the company to insert the producing plant in the Brazil’s official list.
Seafood: all fishery plants must prepare a formal request to NOAA. NOAA will then contact FAS/OAA
and request the registration to be included in the Brazil’s official list.
Registration of U.S. facilities can take more than a year.
VI.II. MAPA’s Inspection Requirements for Plant Products
All unprocessed U.S. products of plant origin (bulk grains, fresh fruits and vegetables, nuts, and seeds)
can only be exported to Brazil if accompanied by an Animal and Plant Health Inspection Service/Plant
Protection and Quarantine (APHIS/PPQ) phytosanitary certificate. Frozen fruits and vegetables do not
need a phytosanitary certificate. U.S. exporters should always check the nearest PPQ office or the
APHIS home page to view the latest import requirements and to see if there is a need to conduct a Pest
Risk Assessment (PRA) of the product before exporting to Brazil.
VI.III. MAPA’s Pest Risk Assessment (PRA)
The importation of plant species, their parts, products, and by-products are regulated by MAPA, due to
the risk of introduction of exotic pests in Brazil. MAPA may define import requirements based on
product risk category, historical interception data, and risk assessment.
A pest risk analysis is mandatory to define specific import requirements for plant species, their parts,
products, and by-products when:
It has never been imported into Brazil;
It is intended for a new use;
It is from a new country of origin;
It has records of importation from a date before August 12, 1997.
PRA will be carried out by Department of Plant Health (DSV) and it shall be conducted according to the
standards approved by MAPA. Should the PRA be necessary, the interested party must contact the DSV
or its superintendents at the state level to initiate the process.
The PRA process can be divided in 3 phases:
PHASE I: START-UP. It involves identification of all disease pathways (hosts) and potential pests
present in the exporting country. This phase is completed via bibliographic survey.
PHASE II: EVALUATON OF PEST RISKS. Pests are evaluated on a case-by-case basis to determine
whether or not they meet the criteria to be considered quarantine pests. Pest characteristics such as
morphology, biology, ecology, means of dispersion, methods of detection, inspections and control
mechanisms and prior presence in the importing country will all be evaluated. Based on this
information, the potential for introduction and potential economic impact will be reviewed and the
determination made as to whether the pest is to be considered a “quarantine.pest.”
PHASE III: PEST RIK MANAGEMENT. The phytosanitary measures that could reduce this risk to an
acceptable level will be identified. According to the information about the pest, the Brazilian National
Organization of Phytosanitary Protection (ONPF) will establish measures to mitigate the risk of
introducing a pest. After the establishment of an appropriate phytosanitary measure, a Regulatory Act
specifying import parameters will be sent by the ONPF to their counterpart in the country of origin-
APHIS. Negotiations between the interested parties may follow, and a final phytosanitary protocol will
be published in Brazil’s Official Gazette.
Interested parties may use the services provided by collaborative centers accredited by MAPA to
develop the phase I of the analyses and pay for their costs.
Products that are exempt from mandatory risk assessment:
A. Products classified as risk category zero (0) and one (1) are exempt from PRA.
Category 0: Products that do not require any type of phytosanitary control due to their degree of
processing, even if they are of plant origin, and therefore do not require NPPO intervention
and.are.not.capable.of.transmitting.pests.in.packaging.material.
Category 1: Plant products, manufactured, devitalized due to the action of any technological process
(cooking, blanching, pasteurization, sterilization, fermentation or others) that changed them into
products that will not be directly affected by pests, but may transmit pests to packaging.materials,
transportation.means.or.storage.
B. Plant species and their parts, products, and by-products that have had at least one shipment imported
in the period between August 12, 1997 and July 16, 2005, provided that it is from the same country of
origin, it serves the same use, it has not presented a record of interception of quarantine pests to Brazil
and provided that it has no specific regulated phytosanitary requirements. Products considered enterable
under this condition are listed as Vegetal Products with Authorized Importation (PVIA) on MAPA’s
webpage.
Given continuous changes occurring in this area, U.S. exporters should check APHIS EXCEPT
database or at the APHIS-IS office in the U.S. Embassy in Brasilia for additional information on the
status of phytosanitary import requirements.
VI.IV. MAPA’s Inspection Requirements for Animal Feed
U.S. exporters of animal feed and fodder, including pet food, must be registered with the Department of
Surveillance of Livestock Inputs (DFIP). The U.S. exporter of animal feed should first establish a legal
representative or importer in Brazil who will file the request for registration of the imported product
with DFIP. The importer must also be registered with MAPA before submitting a request for
registration.
VI.V. MAPA’s Requirements for Alcoholic and Non-alcoholic Beverages
MAPA Normative Instruction no. 54 and no. 55 of November 18th
, 2009 changed import procedures for
alcoholic and non-alcoholic beverages. This regulation establishes formats (presented in ANNEX VIII)
for the certificate of analysis and certificate of origin for beer, distilled spirits, wine and by products,
soft drinks, and juices. MAPA also requires from exporting countries a list of entities eligible to issue
these documents. The list of labs/entities can be found at
(http://sistemasweb.agricultura.gov.br/siscole/consultaPublicaCadastro!consultarCadastro.action).
The Alcohol and Tobacco Tax and Trade Bureau (TTB) has the authority to certify labs and to issue the
certificates of origin for alcoholic beverages. If a lab approved by TTB is not included on MAPA’s list,
TTB can request an update. TTB’s list of Certified Chemists can be found at
(http://www.ttb.gov/ssd/chemist_certification.shtml). As per non-alcoholic beverages, the ATO/Sao
Paulo office should be the primary contact for U.S. companies to get specific information.
VI.VI. ANVISA’s Requirements for Food and Beverage Products
In 2000, ANVISA established the procedures for registration and exemption of registration for imported
food products that fall under the regulatory authority of the Ministry of Health. The objectives of these
rules are to provide guidance to importers and to improve ANVISA’s efficiency in coordinating public
health actions on imported food products.
The request for registration, or exemption from registration, can be made by the legal representative of
the exporting company, a local subsidiary, or by the food importer. If there is more than one importer
for the same product, each importer must make a separate request. The registration is valid for 5 years,
after which a new petition must be filed.
Importers of food products that are exempt from registration are still required to request that the product
be exempt from registration by presenting the appropriate documents to ANVISA. Importers of food
products under mandatory registration must register their products and pay fees, which vary according
to the size of the company.
IMPORTED FOOD PRODUCTS AND PACKAGES EXEMPT FROM REGISTRATION
Sugar and sweeteners
Food additives
Sweeteners for special dietary uses
Purified water salt added
Natural mineral water and natural water
Foods and beverages with nutritional claim (light, zero calories, free, low)
Foods for weight control diets
Foods for nutrient restriction diets
Foods for diets with controlled sugar intake
Foods for pregnant and nursing woman
Foods for elderly
Foods for athletes
Confectionary products (candies and gums)
Coffee, barley, tea, mate and instant products
Chocolate and cocoa products
Processing aids
Packaging
Enzyme and enzyme preparations
Seasonings, condiments and sauces
Edible ices (ice cream)
Ice
Mixes for food preparation and ready to eat products
Vegetable oils, fats and vegetable spreads
Cereal products, starch, flour and meal
Products containing protein of vegetable origin
Vegetable products (exc. Heart of palm), fruit products and edible mushroom (5)
Preserved/canned vegetables
Salt
Hipossodic salt/salt substitutes
Vitamin and/or mineral supplements
IMPORTED FOOD PRODUCTS AND PACKAGES WITH MANDATORY
REGISTRATION
Foods with functional and/or health claim
Infant foods
Foods for enteral nutrition
Packaging from new technologies (recycled)
Novel foods and/or novel ingredients
Bioactive substances and isolated probiotics with functional and/or health claim
Under MAPA, animal origin (meat, fish, dairy and egg products), margarine and honey must be
registered in order to be exported to Brazil. The importer or a legal representative may file a request
with MAPA.
Section VII. Other Specific Standards:
VII. I. Organic Foods
In order to export organic products to Brazil, foreign producers must comply with the Brazilian
regulation for organics, which means that they must be in accordance with the Brazilian production
standards and must also be certified by a compliance body, accredited by MAPA. Foreign producers
must be listed under the National Register of Organic Producers. In practical terms, it means that
exporters must contract a local accredited body to certify each product they intend to sell in Brazil.
The import process follows the standard import procedure. However, additional documents will be
required by the local authorities as organic products, domestic or foreign, must act in accordance with
the organic legislation in force.
Labeling of organic products must follow the requirements below:
one-ingredient products may be labeled as “organic product” once certified;
products made of more than one ingredient, including additives, in which not all the ingredients
are of certified-organic origin, must be labeled in the following manner:
a. mixed products which are a minimum of 95 percent from ingredients of certified organic origin
will be labeled “organic products”;
b. mixed products which are made from 70 to 95 percent from ingredients of certified organic
origin will be labeled as “products with organic ingredients”, and must include the proportions
of the organic and non-organic ingredients on their labels, excluding water and salt from the
calculation;
c. mixed products not meeting the demands of previously-mentioned sections “a” and “b” will not
be labeled as organic.
Any imported product subjected to quarantine treatment not compatible with Brazilian organic
production regulation will lose its organic status. For additional information on organic set of rules,
please access www.agricultura.gov.br/desenvolvimento-sustentavel/organicos.
Section VIII. Copyright and/or Trademark Laws:
The National Institute of Industrial Property (INPI) is a federal agency linked to the Ministry of
Development, Industry and Foreign Trade (MDIC) and it is responsible for registering patents,
industrial designs, trademarks, geographic indications and computer software, among other industrial
property and related rights. Under INPI regulations, registration of patents is valid for 15 (patent of
utility model) to 20 years (patent of invention) from the term of application date. According to the law,
a patent will become extinct on the expiration of the term of protection; on waiver by the patentee
(considering not incur losses for third parties); on forfeiture; on non-payment of annual fee, or on non-
observance of Law 9279 of May 14, 1996, article 217 “a person domiciled abroad must maintain
permanently a duty qualified attorney resident in the country, with powers to represent him
administratively and judicially, including for receiving summons”. The trademark registration certificate
is valid for 10 years from the date it was granted, with the possibility of being renewed for equal and
successive periods. As for geographic indication, its use is restricted to the producers and providers of
servicers established in the locality. Quality requirements will also have to be met referring to
appellations of origin. INPI will establish the conditions of registration for geographic indications. For
general information please access the INPI home page at www.inpi.gov.br.
Section IX. Import Procedures:
Oversight of imported food and beverage products is primarily under the responsibility of MAPA and
ANVISA. These two government bodies ensure the safety of the food supply, and enforce regulations
related to food and beverage products throughout the supply chain.
MAPA ANVISA
Consumer-oriented products
animal products: red meat and by-products,
poultry meat and by-products, fish, seafood
products, dairy products, and eggs;
beverages: alcoholic and non alcoholic (except
energy drinks, hydroelectrolitic beverages, soy
beverages);
fruits and vegetables: dried, fresh and processed
Consumer-oriented products
food:all consumer-ready or processed products,
(except those under MAPA’s authority)
beverages: energy drinks, hydroelectrolitic
beverages and soy beverages
Intermediate products
(wheat flour, planting seeds, etc)
Intermediate products
(sugar, sweeteners, mineral water, flavored
waters, additives, and other ingredients
(excluding those under MAPA’s authority). Bulk commodities
(wheat, grains, rice, soybean, cotton, tobacco,
pulses, peanuts, flour, etc)
Pet food, feeds and fodders
Plants and seeds
Animals, semen and embryos
In Brazil import procedures may be divided into 3 major phases: Import Procedures Prior Shipment,
Import Procedures during Shipment and Import Procedures upon Product Arrival. To go from one
phase to the other, the importer must complete a series of actions. Although the process may vary
according to the product nature, in general terms, the actions under each phase may be presented as
shown below:
IX.I. Import Procedures Prior Shipment
1. Plant Registration
Products regulated by MAPA follow stricter control such as approval of processing plants, registration,
labeling, quota, FPS control, etc. Before initiating exports of animal origin products, U.S. companies
may contact local OAA staff to initiate the registration process and make sure the information to be
provided is acceptable to the Brazilian government.
Prior to exporting alcoholic and non-alcoholic beverages that fall under MAPA’s responsibility, the
exporter must check with ATO Sao Paulo or the Alcohol and Tobacco Tax and Trade Bureau (TTB) to
determine if the laboratory or producer issuing the lab certificate is eligible to do so. MAPA demands
from foreign countries exporting beverages to Brazil to provide a list of entities eligible to issue
laboratory certificates and certificates of origin.
1. Plant Registration
Stricter control is set for animal origin goods, which means that all manufacturing plants must be
approved and registered by MAPA prior to exporting their products to Brazil. To comply with the
Brazilian regulation, U.S. companies may contact the local USDA/FAS/OAA who is responsible for
initiating the registration process with MAPA.
2. Ingredients Evaluation
Brazilian legislation is “positive”, which means that only products (including additives, colorings,
preservatives, etc) that are authorized by Brazilian regulations are allowed to enter the market.
Therefore, the importer must ensure the Brazilian Government (GoB) permits the entry of the foreign
product. All ingredients contained in food or beverage items should meet GoB specifications and
tolerance levels. For that, the Identity and Quality Standard (PIQ) established by MAPA and ANVISA
must be followed.
Under ANVISA, food products containing new ingredients and foods containing ingredients that are
already consumed but with tolerance levels above the Brazilian diet patterns are considered “new
foods”. Such products must be analyzed and approved by ANVISA prior to importation.
3. Labeling
Labeling of food and beverage products must be in accordance to GoB regulations.
4. Product Registration
If the product is allowed to be marketed, the legal representative of the exporting company, (usually a
local subsidiary, or the importer) must request product registration, or an official exemption from
registration. If there is more than one importer for the same product, each importer must make an
independent request.
5. Pro Forma Invoice
The pro forma invoice must be filled out properly otherwise the importer will not be able to file an
import application (delays are very common as a result of inadequate information being reported on the
pro forma invoice).
6. Import License (LI)
With the request for an import authorization the administrative process formally starts. The importer
requests an import permit, also called Import License (LI), which must be obtained before shipment.
IX.II. Import Procedures during Shipment
7. Shipping Instructions
Shipping Instructions consist of a document containing all the information related to the sale and
merchandise’s condition upon shipment, such as the quantity of product, form of payment, transport
temperature, packaging, pallet used, etc. The Shipping Instructions should further contain all the
documents to be sent to the importer.
8. Bill of Lading (B/L) or Airway Bill (AWB)
With the Shipping Instruction provided by the exporter, the shipping company will be able to issue the
B/L or the AWB. This is the proof of loading, issued by the shipping company, containing the entire
description of shipping.
IX.III. Import Procedures upon Product Arrival
9. Notification of Cargo Arrival
Upon arrival, the cargo must be sent to the Customs Terminal (storage). Once the goods are duly
placed, the “presence of Cargo” must be created. This must be done through the SISCOMEX system
and prior the Import Declaration”.
10. Import Declaration (DI)
Once goods arrive in Brazil, the importer (or a contracted customs broker officially representing the
importer), must prepare the Import Declaration (DI) through the SISCOMEX. Mercosul countries
(including Brazil, Argentina, Paraguay and Uruguay), have adopted the Mercosul Common
Nomenclature (NCM) system for product classification. The NCM is based on the international
methodology of the Harmonized Commodity Description and Coding System or simple Harmonized
System (HS). The NCM is formed by 8 digits, the first 6 digits follow the HS codes while the seventh
and eighth digits correspond to Mercosul specifications. Through the NCM the amount of taxes to be
paid are defined.
11. Inspection
Before going through Customs, the importer must present the LI to MAPA or ANVISA officials.
Officials will verify whether or not the cargo was duly authorized and if the documents are accurate.
12. Customs’ Evaluation
The clearance process starts when the product arrives in Brazil. Clearance from customs consists of a
series of acts carried out by a customs official who will authorize the release of the goods to the
importer after the verification of product classification and tax payments. After the reception of
documents, the system will automatically select inspection/verification method to be applied. They are:
GREEN: customs clearance authorization is automatically issued.
YELLOW: mandatory inspection of documentation is required and, if no evidence of
irregularities is found, customs clearance is issued.
RED: mandatory inspection of documentation and of goods is required before customs clearance
authorization is issued.
GRAY: mandatory inspection of documents, merchandise, and recalculation of import taxes
applied.
Except for the green option, all documents including the Import Declaration, the receipt generated by
the SISCOMEX and the Value Added Tax (ICMS) payment receipt (or waiver), must be presented to
the Secretariat of Federal revenue (SRF). For goods assigned the gray option, a Declaration of Customs
Value (DVA) must be made and transmitted via SISCOMEX to justify the product price and
commercial aspects of the transaction. Any correction to the information presented must be carried out
in accordance with SISCOMEX procedures. After registering customs clearance the fiscal authority -
the Secretariat of Federal Revenue - will release an Import Confirmation (CI), approving customs
clearance and the entry of goods.
13. Re-inspection/Product Release
MAPA and ANVISA inspectors must perform a re-inspection before admissibility. The admissibility
will depend on:
Documents review
Physical examination
Lab analysis/sample collection (to be conducted in loco if requested by authorities)
To obtain more detailed information on step-by-step import procedures please contact ATO Sao Paulo.
The ATO has developed a market access study to catalogue administrative procedures and legal
requirements mandated by the GoB for 26 categories of food products. This study analyses actual
procedures followed by importers to comply with government requirements. Always note that the most
updated set of rules each administrative agency releases must be observed prior to shipment as it
directly impacts the entry of foreign goods into Brazil.
Appendix I. Government Regulatory Agency Contacts:
Ministry of Agriculture, Livestock and
Food
Supply (MAPA)
Esplanada dos Ministerios, Bloco D
70043-900 Brasilia, DF
Phone: (55-61) 3218-2510/2468
Home page: www.agricultura.gov.br
Ministry of Health
Agency of Sanitary Surveillance (ANVISA)
Esplanada Dos Ministerios, Bloco B, Ed.Omega
70770-502 Brasilia, DF
Phone: (55-11) 3462-6000
Home page: www.anvisa.gov.br
Ministry of Finance
Brazilian Customs (Receita Federal)
Esplanada dos Ministerios, Bloco P
70048-900 Brasilia, DF
Phone: (55-61) 3412-3000/2000
Home page: www.fazenda.gov.br
Ministry of Development, Industry and Foreign Trade
(MDIC)
Esplanada dos Ministerios, Bloco J
70053-900 Brasilia, DF
Phone: (55-61) 3425-7000
Home page: www.mdic.gov.br
Ministry of Environment (MMA)
Brazilian Environment Institute
(IBAMA)
SCEN, Trecho 2, Ed. Sede
70818-900 Brasilia, DF
Phone: (55-61) 3216-1212
Home page: www.ibama.gov.br
Ministry of Justice (MJ)
Esplanada dos Ministerios, Bloco T
70064-900 Brasilia, DF
Phone: (55-61) 3429-3000
Home page: www.mi.gov.br
Appendix II. Other Import Specialist Contacts:
Brazilian Food Ingredients and Additives Association
(ABIAM)
Rua Hungria, 664, cj. 51
01455-000 Sao Paulo, SP
Phone: (55-11) 3034-3541
E-mail: [email protected]
Home page: www.abiam.com.br
Brazilian Food Processors’ Association
(ABIA)
Av. Brigadeiro Faria Lima, 11 andar
01451-001 Sao Paulo, SP
Phone: (55-11) 3030-1353
E-mail: [email protected]
Home page: www.abia.org.br
Please do not hesitate to contact the Foreign Agricultural Service (FAS) offices below with questions or
comments regarding this report or to request assistance.
Agricultural Trade Office (ATO)
U.S. Consulate General
Rua Thomas Deloney, 381
04710-040 Sao Paulo, SP
Phone: (55-11) 3250-5400
Fax: 955-11) 3250-5499
E-mail: [email protected]
Home page: www.usdabrazil.org.br
www.fas.usda.gov
Office of Agricultural Affairs (OAA)
U.S. Embassy
Av. das Nacoes, quadra 801, lote 3
70403-900 Brasilia, DF
Phone: (55-61) 3312-7101
Fax: (55-61) 3312-7659
E-mail: [email protected]